EMA issues final guidance on antibacterial drug development

Posted May 24, 2022 | By Joanne S. Eglovitch

The European Medicines Agency (EMA) has published final guidance on the evaluation of antibacterial medicines which is broadly aligned with guidance from other regulators.

The EMA said the paper responds to a “pressing need for new antibacterial agents suitable for the treatment of infections in patients with few remaining therapeutic options”.

The agency announced that antimicrobial resistance poses a “global threat” and is responsible for around 33,000 deaths per year with a cost of 1.5 billion euros per year in health care costs and loss of life. productivity.

The publication of the revised guidance follows a public consultation held in 2016 and reflects the results of discussions between regulators in the EU, US and Japan to align their respective data requirements for antibacterial medicines in order to accelerating the development of these drugs around the world.

The guidelines will come into effect on December 1, 2022. They replace an earlier guideline from 2012. The addendum on the evaluation of medicinal products to treat bacterial infections in children has been revised alongside the guidelines. (RELATED: EMA consults on harmonized guidelines for antibacterial drug development, Regulatory guidance January 14, 2019).

The guidelines contain revised recommendations for primary endpoints, primary analysis population, and non-inferiority margins in trials to support certain site-of-infection indications for use. The revision also provides clarification on clinical programs that aim to address an unmet need and includes new guidelines for treating uncomplicated urinary tract infections and uncomplicated gonorrhea.

The update also removes a section on pharmacokinetic and pharmacodynamic development of antibacterials, as these topics are already covered in separate guidelines.

The document applies to antibacterial agents developed as single agents, antibacterial agents developed for use in combination with one or more other specific antibacterial agents, and beta-lactam (BL) agents developed for use with inhibitors of beta-lactamase (BLI).

The EMA said some of the principles covered in the guidance also apply to agents in development that affect bacterial virulence, bacteriophages proposed to treat infections, agents that inhibit bacterial growth and replicate indirectly, and monoclonal antibodies. used as prophylaxis for specific indications.

The guidelines relate to microbiological investigations; general considerations for clinical programs, such as patient selection, clinical evidence of infection at enrollment, and microbiological evidence of infection at enrollment. It also covers sample collection and dosing schedules.

Other topics include when to switch patients from parenteral therapy to oral therapy and how to test antibacterial agents with licensed agents.

Addendum address development antibacterial children

The EMA has also published an addendum dealing with clinical development programs to support medicines intended to treat bacterial infections in children. The guidance, published on May 20, replaces a preliminary version published in April 2018.

The EMA announced that “for the treatment of certain infections, efficacy results can be extrapolated in certain age groups by examining efficacy data in adults. The addendum mentions that companies developing new antibiotics must develop an extrapolation concept and provide agreement on this in an extrapolation plan.

EMA guideline on antimicrobials

EMA Addendum on Development of Pediatric Antibacterials

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